On July 22, 2021, Generex Biotechnology Corporation on behalf of itself and its subsidiary NuGenerex Immuno-Oncology Inc. (collectively “Generex”) entered into a Quality Agreement with PPD Development, L.P. (“PPD”) regarding Generex’s efforts to develop Generex’s li- Key-SARS-CoV-2 coronavirus peptide vaccine (the “Quality Agreement”). The Quality Agreement describes the standards, expectations, and responsibilities of Generex and PPD with respect to managing quality, including, but not limited to, quality assurance (QA) and quality risk management (QRM) for the services and/or deliverables. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. PPD’s customers include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and approximately 24,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help customers bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health. The Ii-Key-SARS-CoV-2 vaccine is designed as a “Complete Vaccine” that has the potential to induce the T-Cell and antibody immune responses that can provide protective immunity with long-lasting immunologic memory against SARS-CoV-2 in a highly specific manner to ensure safety. Ii-Key is a platform technology enabled by the amino acid key sequence “LRMK” that is shared across the platform. The LRMK key sequence works by its ability to deliver any desired peptide epitope of interest directly to the MHC Class 2 complex on the surface of antigen presenting cells. Once a suitable target epitope is identified, an Ii-Key vaccine candidate is created by means of synthetic peptide synthesis, which produces a single linear amino acid chain that includes the Ii-Key sequence, a short inert linker sequence, and the target epitope of interest. In this way, the target epitope is delivered by the Ii-Key sequence directly to antigen presenting cells, resulting in an immune system stimulation.